BACKGROUND: To compare the results of HbA1c determination obtained through immunoassays versus the HPLC method currently used routinely in our laboratory. METHODS: We evaluated immunoturbidimetric assays for the HbA1c measure on three analyzers, specifically the Roche Cobas Integra 400+ (Roche Diagnostics, Indianapolis, IN, USA), Ortho Clinical Diagnostics Vitros 5.1 FS (Ortho Clinical Diagnostics, NY, USA), and Siemens Dimension RxL (Siemens Healthcare Diagnostics, NY, USA), in comparison with the HPLC Menarini HA 8140 (Menarini Diagnostics, Rungis, France) currently used in our laboratory. RESULTS: Analytical performances including precision, analytical range, recovery, carryover, erythrosedimentation and comparison studies were acceptable leading to results with a level of exactitude in accordance with the recommendations of the National Glycohemoglobin Standardization Program (NGSP). CONCLUSIONS: The three immunoassays tested can be used interchangeably and will be satisfactory for laboratories who cannot invest in a HPLC analyzer.
BACKGROUND: To compare the results of HbA1c determination obtained through immunoassays versus the HPLC method currently used routinely in our laboratory. METHODS: We evaluated immunoturbidimetric assays for the HbA1c measure on three analyzers, specifically the Roche Cobas Integra 400+ (Roche Diagnostics, Indianapolis, IN, USA), Ortho Clinical Diagnostics Vitros 5.1 FS (Ortho Clinical Diagnostics, NY, USA), and Siemens Dimension RxL (Siemens Healthcare Diagnostics, NY, USA), in comparison with the HPLC Menarini HA 8140 (Menarini Diagnostics, Rungis, France) currently used in our laboratory. RESULTS: Analytical performances including precision, analytical range, recovery, carryover, erythrosedimentation and comparison studies were acceptable leading to results with a level of exactitude in accordance with the recommendations of the National Glycohemoglobin Standardization Program (NGSP). CONCLUSIONS: The three immunoassays tested can be used interchangeably and will be satisfactory for laboratories who cannot invest in a HPLC analyzer.
Authors: Deepti Gurdasani; Tommy Carstensen; Segun Fatumo; Guanjie Chen; Chris S Franklin; Javier Prado-Martinez; Heleen Bouman; Federico Abascal; Marc Haber; Ioanna Tachmazidou; Iain Mathieson; Kenneth Ekoru; Marianne K DeGorter; Rebecca N Nsubuga; Chris Finan; Eleanor Wheeler; Li Chen; David N Cooper; Stephan Schiffels; Yuan Chen; Graham R S Ritchie; Martin O Pollard; Mary D Fortune; Alex J Mentzer; Erik Garrison; Anders Bergström; Konstantinos Hatzikotoulas; Adebowale Adeyemo; Ayo Doumatey; Heather Elding; Louise V Wain; Georg Ehret; Paul L Auer; Charles L Kooperberg; Alexander P Reiner; Nora Franceschini; Dermot Maher; Stephen B Montgomery; Carl Kadie; Chris Widmer; Yali Xue; Janet Seeley; Gershim Asiki; Anatoli Kamali; Elizabeth H Young; Cristina Pomilla; Nicole Soranzo; Eleftheria Zeggini; Fraser Pirie; Andrew P Morris; David Heckerman; Chris Tyler-Smith; Ayesha A Motala; Charles Rotimi; Pontiano Kaleebu; Inês Barroso; Manj S Sandhu Journal: Cell Date: 2019-10-31 Impact factor: 41.582